Biocompatibles UK Limited
UK-MF-000052971 · United Kingdom · Surrey
Biocompatibles UK Limited is registered in the European database on medical devices as a manufacturer, with 42 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: TheraSphere Administration Set (B Braun); Box of 20, TheraSphere Administration Set (B Braun); Single, TheraSphere Yttrium-90 Glass Microspheres – 11.5 GBq, TheraSphere Yttrium-90 Glass Microspheres – 14.0 GBq, TheraSphere Yttrium-90 Glass Microspheres – 14.5 GBq.
Among these devices, 40 are declared sterile, 35 implantable, 35 active.
Authorised representative in the Union: Donawa Lifescience Consulting Srl.
Devices declared under this manufacturer
- TheraSphere Administration Set (B Braun)
Showing 12 of 42 declared devices.
Catalogue references include OTT-SPE-FP-001, OTT-SPE-FP-226, OTT-SPE-FP-617, OTT-SPE-FP-700.
European nomenclature codes declared: J0501, J0502, J0580.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 42 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 42 |
|---|---|
| Found in the U.S. device database | 42 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOCOMPATIBLES UK LIMITED |
North American profile: Canada only. Biocompatibles UK Limited holds a Canadian licence but was not found in the U.S. register.